83 FR 9004 - Standardization of Data and Documentation Practices for Product Tracing; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 42 (March 2, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 42 (March 2, 2018)
| Page Range | 9004-9006 | |
| FR Document | 2018-04180 |
[Federal Register Volume 83, Number 42 (Friday, March 2, 2018)] [Notices] [Pages 9004-9006] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-04180] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-0688] Standardization of Data and Documentation Practices for Product Tracing; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Standardization of Data and Documentation Practices for Product Tracing.'' The draft guidance elaborates on the standards for the interoperable exchange of transaction information, transaction history, and transaction statements (product tracing information) [[Page 9005]] provided under the drug supply chain security provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance is intended to assist trading partners in standardizing the data contained in the product tracing information that trading partners must provide, capture, and maintain under the FD&C Act. In addition, this guidance includes recommendations for documentation practices that a trading partner can use to meet its product tracing obligations, including in situations where a trading partner is permitted by law to provide other trading partners with product tracing information that omits certain elements that would otherwise be required. DATES: Submit either electronic or written comments on the draft guidance by May 1, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2018-D-0688 for ``Standardization of Data and Documentation Practices for Product Tracing; Draft Guidance for Industry; Availability.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Connie Jung, Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3130, [email protected]. SUPPLEMENTARY INFORMATION: I. Background On November 27, 2013, the Drug Supply Chain Security Act (Title II of Pub. L. 113-54) was signed into law. Section 202 of the Drug Supply Chain Security Act (DSCSA), which added new sections 581 and 582 to the FD&C Act (21 U.S.C. 360eee and 360eee-1), set forth new definitions and requirements related to product tracing. The DSCSA outlines critical steps to build an electronic, interoperable system by November 27, 2023, that will identify and trace certain prescription drugs as they are distributed within the United States. Under section 582(b)(1), (c)(1), (d)(1), and (e)(1) of the FD&C Act, certain trading partners in the pharmaceutical distribution supply chain (manufacturers, wholesale distributors, dispensers, and repackagers) are required to capture, maintain, and provide the subsequent purchaser of certain prescription drug products with product tracing information. These requirements took effect on January 1, 2015, for manufacturers, wholesale distributors, and repackagers, and on July 1, 2015, for dispensers. As required by section 582(a)(2)(A) of the FD&C Act, FDA established initial standards in 2014 to facilitate the interoperable exchange of transaction information, transaction history, and transaction statements between trading partners (79 FR 70878, November 28, 2014). Those standards help trading partners comply with the requirements of section 582(b)(1), (c)(1), (d)(1), and (e)(1) of the FD&C Act to provide the subsequent trading partners with product tracing information, in paper or electronic format, through the extension and/or use of current systems and processes. [[Page 9006]] This draft guidance elaborates on the initial standards that FDA established in 2014. It is intended to assist trading partners in standardizing the data that are contained in the product tracing information they must provide to subsequent purchasers. It is also intended to help trading partners understand the data elements that should be included in the product tracing information, particularly in situations where they are permitted by law to provide other trading partners with product tracing information that omits certain elements that would otherwise be required. In addition, the draft guidance recommends documentation practices that trading partners can use to satisfy the requirements of section 582(b)(1), (c)(1), (d)(1), and (e)(1) of the FD&C Act. This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA about standardization of data and documentation practices for the exchange of product tracing information. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866. II. Paperwork Reduction Act of 1995 This draft guidance includes information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). FDA intends to solicit public comment and obtain OMB approval for any information collections recommended in this guidance that are new or that would represent modifications to those previously approved collections of information found in FDA regulations or guidances. III. Electronic Access Persons with access to the internet may obtain the document at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or https://www.regulations.gov. Dated: February 23, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-04180 Filed 3-1-18; 8:45 am] BILLING CODE 4164-01-P
![9004 Federal Register / Vol. 83, No. 42 / Friday, March 2, 2018 / Notices
Staff, FDA will post your comment, as Staff, 5630 Fishers Lane, rm. 1061, number of small entities. In compliance
well as any attachments, except for Rockville, MD 20852. with section 212 of the Small Business
information submitted, marked and You may submit comments on any Regulatory Enforcement Fairness Act
identified, as confidential, if submitted guidance at any time (see 21 CFR (Pub. L. 104–121, as amended by Pub.
as detailed in ‘‘Instructions.’’ 10.115(g)(5)). L. 110–28), we are making available the
Instructions: All submissions received Submit written requests for single SECG to explain the actions that a small
must include the Docket No. FDA– copies of the SECG to the Office of entity must take to comply with the
2004–N–0258 for ‘‘Food Labeling: Nutrition and Food Labeling, Center for rule.
Serving Sizes of Foods That Can Food Safety and Applied Nutrition We are issuing the SECG consistent
Reasonably Be Consumed at One Eating (HFS–800), Food and Drug with our good guidance practices
Occasion; Dual-Column Labeling; Administration, 5001 Campus Dr., regulation (21 CFR 10.115(c)(2)). The
Updating, Modifying, and Establishing College Park, MD 20740. Send two self- SECG represents the current thinking of
Certain Reference Amounts Customarily addressed adhesive labels to assist that FDA on this topic. It does not establish
Consumed; Serving Size for Breath office in processing your request. See any rights for any person and is not
Mints; and Technical Amendments— the SUPPLEMENTARY INFORMATION section binding on FDA or the public. You can
Small Entity Compliance Guide.’’ for electronic access to the SECG. use an alternative approach if it satisfies
Received comments will be placed in FOR FURTHER INFORMATION CONTACT: the requirements of the applicable
the docket and, except for those Jillonne Kevala, Center for Food Safety statutes and regulations. This guidance
submitted as ‘‘Confidential and Applied Nutrition, Food and Drug is not subject to Executive Order 12866.
Submissions,’’ publicly viewable at Administration, 5001 Campus Dr.,
https://www.regulations.gov or at the II. Paperwork Reduction Act of 1995
College Park, MD 20740, 240–402–1450.
Dockets Management Staff between 9 The guidance refers to previously
SUPPLEMENTARY INFORMATION:
a.m. and 4 p.m., Monday through approved collections of information
Friday. I. Background found in FDA regulations. The
• Confidential Submissions—To collections of information in §§ 101.9
submit a comment with confidential In the Federal Register of May 27,
and 101.12 have been approved under
information that you do not wish to be 2016 (81 FR 34000), we issued a final
OMB control number 0910–0381.
made publicly available, submit your rule pertaining to serving sizes for food.
comments only as a written/paper The final rule amends the definition of III. Electronic Access
submission. You should submit two a single-serving container; requires Persons with access to the internet
copies total. One copy will include the dual-column labeling for certain may obtain the SECG at either https://
information you claim to be confidential containers; updates, modifies, and www.fda.gov/FoodGuidances or https://
with a heading or cover note that states establishes certain Reference Amounts www.regulations.gov. Use the FDA
‘‘THIS DOCUMENT CONTAINS Customarily Consumed (RACCs); website listed in the previous sentence
CONFIDENTIAL INFORMATION.’’ We amends the serving size for breath to find the most current version of the
will review this copy, including the mints; and makes certain technical guidance.
claimed confidential information, in our amendments to various aspects of
Dated: February 27, 2018.
consideration of comments. The second preexisting serving size regulations. The
final rule, which is codified at §§ 101.9 Leslie Kux,
copy, which will have the claimed
and 101.12 (21 CFR 101.9 and 101.12), Associate Commissioner for Policy.
confidential information redacted/
became effective July 26, 2016, and has [FR Doc. 2018–04284 Filed 3–1–18; 8:45 am]
blacked out, will be available for public
viewing and posted on https:// a compliance date of July 26, 2018, for BILLING CODE 4164–01–P
www.regulations.gov. Submit both manufacturers with $10 million or more
copies to the Dockets Management Staff. in annual food sales, and July 26, 2019,
for manufacturers with less than $10 DEPARTMENT OF HEALTH AND
If you do not wish your name and
million in annual food sales. On HUMAN SERVICES
contact information to be made publicly
available, you can provide this October 2, 2017, FDA published a
Food and Drug Administration
information on the cover sheet and not proposed rule to extend the compliance
in the body of your comments and you dates by approximately 1.5 years—to [Docket No. FDA–2018–D–0688]
must identify this information as January 1, 2020, for manufacturers with
‘‘confidential.’’ Any information marked $10 million or more in annual food sales Standardization of Data and
as ‘‘confidential’’ will not be disclosed and to January 1, 2021, for Documentation Practices for Product
except in accordance with 21 CFR 10.20 manufacturers with less than $10 Tracing; Draft Guidance for Industry;
and other applicable disclosure law. For million in annual food sales—and Availability
more information about FDA’s posting explained that, pending completion of AGENCY: Food and Drug Administration,
of comments to public dockets, see 80 the rulemaking with respect to the HHS.
FR 56469, September 18, 2015, or access compliance dates, we intend to exercise ACTION: Notice of availability.
the information at: https://www.gpo.gov/ enforcement discretion with respect to
fdsys/pkg/FR-2015-09-18/pdf/2015- the compliance dates announced in the SUMMARY: The Food and Drug
23389.pdf. final rule (82 FR 45753). A final Administration (FDA or Agency) is
Docket: For access to the docket to determination regarding the compliance announcing the availability of a draft
read background documents or the dates is pending. guidance for industry entitled
daltland on DSKBBV9HB2PROD with NOTICES
electronic and written/paper comments We examined the economic ‘‘Standardization of Data and
received, go to https:// implications of the final rule as required Documentation Practices for Product
www.regulations.gov and insert the by the Regulatory Flexibility Act (5 Tracing.’’ The draft guidance elaborates
docket number, found in brackets in the U.S.C. 601–612) and determined that on the standards for the interoperable
heading of this document, into the the final rules on nutrition labeling, exchange of transaction information,
‘‘Search’’ box and follow the prompts taken as a whole, will have a significant transaction history, and transaction
and/or go to the Dockets Management economic impact on a substantial statements (product tracing information)
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![9006 Federal Register / Vol. 83, No. 42 / Friday, March 2, 2018 / Notices
This draft guidance elaborates on the DEPARTMENT OF HEALTH AND comments, that information will be
initial standards that FDA established in HUMAN SERVICES posted on https://www.regulations.gov.
2014. It is intended to assist trading • If you want to submit a comment
partners in standardizing the data that Food and Drug Administration with confidential information that you
are contained in the product tracing [Docket No. FDA–2016–D–1255]
do not wish to be made available to the
information they must provide to public, submit the comment as a
subsequent purchasers. It is also E18 Genomic Sampling and written/paper submission and in the
intended to help trading partners Management of Genomic Data; manner detailed (see ‘‘Written/Paper
understand the data elements that International Council for Submissions’’ and ‘‘Instructions’’).
should be included in the product Harmonisation; Guidance for Industry; Written/Paper Submissions
tracing information, particularly in Availability
situations where they are permitted by Submit written/paper submissions as
law to provide other trading partners AGENCY: Food and Drug Administration, follows:
with product tracing information that HHS. • Mail/Hand delivery/Courier (for
ACTION: Notice of availability. written/paper submissions): Dockets
omits certain elements that would
Management Staff (HFA–305), Food and
otherwise be required. In addition, the SUMMARY: The Food and Drug Drug Administration, 5630 Fishers
draft guidance recommends Administration (FDA or Agency) is Lane, Rm. 1061, Rockville, MD 20852.
documentation practices that trading announcing the availability of a • For written/paper comments
partners can use to satisfy the guidance for industry entitled ‘‘E18 submitted to the Dockets Management
requirements of section 582(b)(1), (c)(1), Genomic Sampling and Management of Staff, FDA will post your comment, as
(d)(1), and (e)(1) of the FD&C Act. Genomic Data.’’ The guidance was well as any attachments, except for
This draft guidance is being issued prepared under the auspices of the information submitted, marked and
consistent with FDA’s good guidance International Council for Harmonisation identified, as confidential, if submitted
practices regulation (21 CFR 10.115). (ICH), formerly the International as detailed in ‘‘Instructions.’’
The draft guidance, when finalized, will Conference on Harmonisation. This Instructions: All submissions received
represent the current thinking of FDA guidance focuses on the general must include the Docket No. FDA–
about standardization of data and principles of collecting, processing, 2016–D–1255 for ‘‘E18 Genomic
documentation practices for the transporting, storing, and disposing of Sampling and Management of Genomic
exchange of product tracing genomic samples or data in clinical Data; International Council for
information. It does not establish any studies. The guidance is intended to Harmonisation; Guidance for Industry.’’
rights for any person and is not binding provide harmonized principles of Received comments will be placed in
on FDA or the public. You can use an genomic sampling and of management the docket and, except for those
alternative approach if it satisfies the of genomic data in clinical studies to submitted as ‘‘Confidential
requirements of the applicable statutes foster interactions amongst Submissions,’’ publicly viewable at
and regulations. This guidance is not stakeholders, including drug https://www.regulations.gov or at the
subject to Executive Order 12866. developers, investigators, and Dockets Management Staff between 9
II. Paperwork Reduction Act of 1995 regulators; and to encourage genomic a.m. and 4 p.m., Monday through
research within clinical studies. Friday.
This draft guidance includes
DATES: The announcement of the • Confidential Submissions—To
information collection provisions that
guidance is published in the Federal submit a comment with confidential
are subject to review by the Office of
Register on March 2, 2018. information that you do not wish to be
Management and Budget (OMB) under
ADDRESSES: You may submit either made publicly available, submit your
the Paperwork Reduction Act of 1995
electronic or written comments on comments only as a written/paper
(PRA) (44 U.S.C. 3501–3520). FDA
Agency guidances at any time as submission. You should submit two
intends to solicit public comment and
follows: copies total. One copy will include the
obtain OMB approval for any
information you claim to be confidential
information collections recommended Electronic Submissions with a heading or cover note that states
in this guidance that are new or that
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
would represent modifications to those
following way: CONFIDENTIAL INFORMATION.’’ The
previously approved collections of
• Federal eRulemaking Portal: Agency will review this copy, including
information found in FDA regulations or
https://www.regulations.gov. Follow the the claimed confidential information, in
guidances.
instructions for submitting comments. its consideration of comments. The
III. Electronic Access Comments submitted electronically, second copy, which will have the
Persons with access to the internet including attachments, to https:// claimed confidential information
may obtain the document at https:// www.regulations.gov will be posted to redacted/blacked out, will be available
www.fda.gov/Drugs/Guidance the docket unchanged. Because your for public viewing and posted on
ComplianceRegulatoryInformation/ comment will be made public, you are https://www.regulations.gov. Submit
Guidances/default.htm, https:// solely responsible for ensuring that your both copies to the Dockets Management
www.fda.gov/BiologicsBloodVaccines/ comment does not include any Staff. If you do not wish your name and
GuidanceComplianceRegulatory confidential information that you or a contact information to be made publicly
Information/Guidances/default.htm, or third party may not wish to be posted, available, you can provide this
daltland on DSKBBV9HB2PROD with NOTICES
https://www.regulations.gov. such as medical information, your or information on the cover sheet and not
anyone else’s Social Security number, or in the body of your comments and you
Dated: February 23, 2018. confidential business information, such must identify this information as
Leslie Kux, as a manufacturing process. Please note ‘‘confidential.’’ Any information marked
Associate Commissioner for Policy. that if you include your name, contact as ‘‘confidential’’ will not be disclosed
[FR Doc. 2018–04180 Filed 3–1–18; 8:45 am] information, or other information that except in accordance with 21 CFR 10.20
BILLING CODE 4164–01–P identifies you in the body of your and other applicable disclosure law. For
VerDate Sep<11>2014 18:10 Mar 01, 2018 Jkt 244001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\02MRN1.SGM 02MRN1](https://thefederalregister.org/doc/83_FR_9046/page/3.svg)
Document Created: 2018-03-01 23:57:12
Document Modified: 2018-03-01 23:57:12
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | Submit either electronic or written comments on the draft guidance by May 1, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Connie Jung, Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3130, [email protected] | |
| FR Citation | 83 FR 9004 |
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